510(k) · Cleared
ClearedProbe Covers for Thermometers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K-Jump Health Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Sep 24, 2018 as substantially equivalent to K102508 (Yu Long Sheng Technology Co., Ltd., 2011) after a 189-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Sep 24, 2018
- Review
- 189 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871465 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK871465 Thermometer SheathsAbco Dealers, Inc. · 1987
- 3 generations backK983406 Sanitherm Oral Disposable Thermometer Sheaths for Mercury…Banta Healthcare Group, Ltd. · 1998
- 2 generations backK061007 Good Medy, Disposable Thermometer SheathsGood Medy Enterprise, Ltd. · 2006
- 1 generation backK102508 YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02Yu Long Sheng Technology Co., Ltd. · 2011
- This deviceK180714 Probe Covers for ThermometersK-Jump Health Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871465 | Thermometer Sheaths | Abco Dealers, Inc. | 1987 | — |
| −3 | K983406 | Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer… | Banta Healthcare Group, Ltd. | 1998 | — |
| −2 | K061007 | Good Medy, Disposable Thermometer Sheaths | Good Medy Enterprise, Ltd. | 2006 | — |
| −1 | K102508 | YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02 | Yu Long Sheng Technology Co., Ltd. | 2011 | — |
| 0 (this device) | K180714 | Probe Covers for Thermometers | K-Jump Health Co., Ltd. | 2018 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102508 | YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02Summary page 4…II Product Code: FLL 3. Predicate Device Device Name 510(k) Number Decision Date Yu Long Sheng Disposable K102508 01/10/2011 Thermometer Sheath (YU LONG SHENG TECHNOLOGY CO., LTD.) This predicate has not been subject to a design… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 7.7 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K102508.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Probe Covers for Thermometers are intended for use as barriers between thermometers and oral cavities or users' rectum. The subject devices are used as accessories for digital thermometers and intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180714: Probe Covers for Thermometers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180714
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026